Supreme Court Gets It Right in Difficult Gene Case|
In June of this year, the U.S. Supreme Court decided a case involving the patentability of human genes. According to the Court, human genes in and of themselves are not patentable, but synthetic replications of them are. The issue before the Court was whether the patent holder had the exclusive right to isolate certain genes and to synthetically replicate those genes. The Court decided that the answer to the former question was no, and the answer to the latter question was yes (with the caveat that the synthetic replications are not the same as the naturally occurring genes).
In Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), three of Myriad's patents were at issue. These patents covered not only the actual DNA sequences themselves but also nucleotide sequences for complementary DNA (cDNA), which is synthetically created DNA that omits portions of the DNA segment that do not code for proteins. In other words, the patents covered not only DNA as it exists in nature but also a man-made, synthetic form of DNA that does not exist in nature and that was created for diagnostic purposes. Specifically, the cDNA contains only the exons and omits the introns that are normally present in DNA.
The specific genes that Myriad patented are the genes that govern susceptibility to breast and ovarian cancer. Myriad discovered the location and sequence of these genes and used this information to develop diagnostic tests that inform women as to their risk of developing these types of cancers. When other companies developed similar tests (and typically charged less money for them), Myriad sued for infringement of its patents, and the accused companies challenged the validity of those patents.
In reaching its conclusion, the Court reasoned that products of nature are not eligible for patent protection, but
something that is not naturally occurring is. (For example, you cannot find a plant in the woods and patent it, but you could patent the use of that plant for medicinal purposes.) Even brilliant discoveries--such as Myriad's discovery that mutations of the BRCA1 and BRCA2 genes increase the risk of certain cancers--are not patentable if they involve simply discovering a fact of nature. The same is true of extensive effort--no matter how great the investment in time and personnel, extensive effort alone is irrelevant to the patentability analysis.
The controversial issue--and one that has been the subject of many debates in intellectual property forums across the country--was whether the isolation of certain genes from the rest of the DNA strand should be patentable. The issue of the patentability of the cDNA was less controversial because cDNA does not occur in nature. According to the Court, the mere act of isolating a gene, by severing the covalent bonds that bind it to the rest of the chromosome, is not an act of invention. (My analogy is that this would be like picking a leaf off of a tree and attempting to patent the leaf.) In the latter instance, the Court reasoned, Myriad did not create anything. On the other hand, cDNA is not the same as a naturally occurring DNA segment because it is an exons-only molecule. Because it is "distinct from the DNA from which it is derived," the Court held that it is patentable.
Finally, the Court noted that if Myriad had attempted to patent novel methods of isolating the DNA strands, those claims may have been upheld--but the methods Myriad used were well-known in the industry. The Myriad patents also included claims for applications of its knowledge concerning the BRCA1 and BRCA2 genes (as in the above analogy regarding patenting the use of a plant for medicinal purposes), but those claims were not challenged. In patent parlance, the challenged claims were "composition" claims that went to the gene sequences themselves.